Gelato Apf

Gelato Apf Recall

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Questions & Answers

Side Effects & Adverse Reactions

Keep out of reach of children.
Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a poison control center right away.
Read directions carefully before using.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For professional office use only. This product is not intended for home or unsupervised consumer use.

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Sources

Gelato Apf Manufacturers

Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat of drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Pd-rx Pharmaceuticals, Inc.

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with ibuprofen tablets the dose and frequency should be adjusted to suit an individual patient's needs.
Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer Ibuprofen Tablets, USP with meals or milk.
Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease:
Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).
Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.
The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption). The availability of four tablet strengths facilitates dosage adjustment.
In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.
In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.
Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectivess).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Rhodes Pharmaceuticals L.p.

2.1 General Dosing Information
The recommended starting dose of APTENSIO XR for patients 6 years and above is 10 mg once daily in the morning with or without food. Advise patients to establish a routine pattern with regard to meals. The dose should be individualized according to the needs and response of the patient.
The dose may be titrated weekly in increments of 10 mg. Daily doses above 60 mg have not been studied and are not recommended.
APTENSIO XR may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.
Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of APTENSIO XR, and adjust dosage as needed.
2.2 Dose Reduction and Discontinuation
If paradoxical aggravation of symptoms or other adverse reactions occur; the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
2.3 Important Information Prior to Initiating Treatment
Prior to treating pediatric patients and adults with CNS stimulants including APTENSIO XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions 5.2].
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for APTENSIO XR use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expecorate any excess gel and do not eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and do not eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used a preventative caries treatment two times a year.
1. After thorough propylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth,
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

Gelato Apf | Perrigo New York Inc

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

No Recall

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